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    Home > Active Ingredient News > Drugs Articles > Grab the first imitation! Analysis of the expiration of patents for chemical drugs in China in the next 5 years

    Grab the first imitation! Analysis of the expiration of patents for chemical drugs in China in the next 5 years

    • Last Update: 2020-12-20
    • Source: Internet
    • Author: User
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    The research and development cost of generic drugs is low and the market demand is huge.
    the future, generic drug development still has significant opportunities as the cost and difficulty of developing and approval of new molecular real drugs continue to increase, and the peak of patent drug failures approaches.
    On September 11, 2020, the State Drug Administration and the State Intellectual Property Office issued the Measures for the Implementation of the Early Settlement Mechanism for Drug Patent Disputes (Trial) (Draft for Comments), in which Article 11 stipulates that the first chemical generic drug to challenge a patent and the first approved for listing shall be given exclusive market access, and the drug regulatory department under the State Council shall not approve the listing of generic drugs of the same variety within 12 months from the date of approval of the drug.
    Under the dual interests of national policies and market prospects, due to information asymmetry, technical difficulties and the small size of the market for some rare disease drugs, the pace of follow-up of domestic generic drugs is still very slow, many drug varieties that are about to expire, there are no enterprises to apply for imitation registration.
    if pharmaceutical companies do not begin to act until after the expiration of the original drug patent, there will be a lot of generic drugs in the market, with the original drug to compete for market share, so that the market value is greatly reduced.
    Therefore, pharmaceutical companies should grasp the information of expiring drugs as soon as possible, explore their own advantages in many aspects, break through the patent barriers set by the original pharmaceutical companies, do a good job in the development of targeted drugs, and form a series of perfect patent strategy to help the rapid introduction of their own imitation products after the expiration of drug patents.
    Global Listed Chemicals Analysis According to the Pharmaceutical Rubik's Cube NextPharma database, as of November 25, 2020, there were more than 4,300 approved chemicals approved for sale worldwide, as shown in the following illustration of the research and development phase in China.
    Of these, only 802 chemicals were approved for listing in China, 55 were applied for listing, 114 were declared clinical, 95 were in clinical research and 3,245 were not declared in China.
    Among the domestic non-declared chemicals that are due to expire within five years, such as idelalisib, rucaparib, pimavanserin, etc., as well as some U.S. compound patents that have not yet expired but are not domestic patents for compounds, such as obeticolic acid and pitolisant.
    data sources: Pharmaceutical Rubik's Cube NextPharma Worldwide has been approved for the market of chemicals mainly distributed in infection, cardiovascular disease, oncology and other fields, the main original research companies for Pfizer, Novarma, Merca East, Sanofi, GlaxoSmithKline, Roche and so on.
    source: Pharmaceutical Rubik's Cube NextPharma Worldwide has been approved for the patent layout of chemical drugs.
    In the case of Adrani, ICOS Corporation and Gilead Calistoga LLC have laid out patents for compounds, crystallines, pharmaceutical uses, intermediates/synthetic methods, combined drugs, etc., as follows (data show that the same-family patents are selected in the order in which CN>US and WO and authorization fail).
    source: Pharmaceutical Rubik's Cube NextPharma China patent expired drug species analysis patent is an important factor affecting the market conditions of original drugs and generic drugs, determine the success or failure of pharmaceutical companies.
    , so-called patented drugs expire, usually referring to the expiration of the drug's underlying patents, such as compound patents.
    only if the underlying patent expires will it be possible to replicate it.
    According to the Pharmaceutical Rubik's Cube GenesPick database, as of November 25, 2020, there are 83 Phase III clinical-listed chinese compound patents in China that will expire in the next 5 years, with a total of 94 varieties differentiated by dosage form.
    the dosage form distribution and disease areas of these 94 varieties are shown in the figure below.
    source: Pharmaceutical Rubik's Cube GenericsPick Source: Pharmaceutical Rubik's Cube GenericsPick 94 Phase III drugs due to expire in the next five years - 5 of the drugs on the market with higher sales in 2019 Varieties as shown in the table below data sources: Pharmaceutical Rubik's Cube IPM (National Hospital Terminal) domestic pharmaceutical companies imitation strategy China as a large producer of generic drugs, currently 70% of domestic pharmaceutical products are generic drugs, about 90% of local pharmaceutical enterprises to generic drug business."
    But from the actual situation of the market, because the quality of China's domestic generic drugs is not high, its market share is very small, it is difficult to export abroad, the original drug after the patent period in China's market share is often still more than half, which is very different from the widespread "patent cliff" phenomenon in other countries.
    In order to win a certain market share, the future pharmaceutical industry must change the existing development concept, do a good job in the following aspects: 1) in advance screening varieties, competition for the first imitation: the pharmaceutical industry in conjunction with its own development strategy to determine the target market, timely access to the potential drug data for the expiration of patents, and the market size, competition, route difficulties, patent obstacles, etc. analysis, select potential varieties.
    2) Focus on the combination of imitation, strengthen innovation: increase investment in innovative research and development stage, in innovation there is imitation, in imitation there is innovation, imitation, innovation combined, possible improvement of the aspects of timely secondary innovation, the production of higher quality drugs, establish their own technological advantages.
    3) Improve the patent layout and seize the market: dig deep into the patent layout of the original research drug, find the layout blank points or patent gaps with development potential, form the innovation achievements of crystal, process, dosage form in the process of breaking through the "patent barrier", and carry out patent protection in a timely manner, through applications including intermediates, synthesis methods, crystal forms, processes, compositions, preparations, etc. Patents such as new adaptations and drug supply devices, reasonable arrangements for each type of patent application time, application area, combing the patent protection level, forming the patent layout of generic drugs, prevent the original pharmaceutical companies from licensing generic pharmaceutical enterprises, and prevent other generic drug companies from copying, to ensure that enterprises occupy the status of first generic drugs, in the market to contribute high-quality generic drugs at the same time to create higher benefits for enterprises.
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